MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TL (REF 043.051S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.1mm, RN, SLA 8mm, Ti · Class 2 · Implant
Quick summary
This Straumann ITI dental implant is placed in the jawbone. Reports most often describe the implant failing to fuse with the bone, and some mention scar-like tissue, infection, pain and tissue damage. The device appears in 4,800 reports, with 4,800 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 4,811
- Deaths reported
- 0
- Injuries reported
- 4,811
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,811 adverse event reports that list this exact device (DI 07630031700919), received between Aug 29, 2019 and Sep 28, 2026 — classified as 4,811 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2,491 reports).
1 other recall cover devices cleared under the same FDA submission (K033922); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration2,491
- Failure to Osseointegrate2,298
- Adverse Event Without Identified Device or Use Problem44
- Fracture43
- Unintended Movement11
- Therapeutic or Diagnostic Output Failure3
- Unstable3
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions2,376
- Fibrosis1,094
- Unspecified Infection780
- Tissue Damage773
- Pain728
- Inflammation303
- Hemorrhage/Blood Loss/Bleeding274
- Swelling/ Edema135
Recent adverse event reports
The 25 most recent of 4,811 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50920543 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919537 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation
MAUDE report 50807073 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806723 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806707 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759989 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50759668 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation
MAUDE report 50759639 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720104 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50719159 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654405 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653661 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653409 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in the patient's mouth. On (b)(6)2026 non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481713 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in the patient's mouth. On (B)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480987 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416263 ↗InjuryAug 14, 2026Loss of Osseointegration
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 50258754 ↗InjuryAug 13, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238399 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2015 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50199173 ↗InjuryAug 6, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2020(b)(6) in FDI 15. On 2026(b)(6), loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50163151 ↗InjuryAug 6, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2024(b)(6) in FDI 26. On 2026(b)(6), loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50163016 ↗InjuryAug 6, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2014 in FDI 37. Details of surgery: Implant surface not completely covered with bone. On (b)(6)2026, loss of osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50162713 ↗InjuryAug 3, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50120028 ↗InjuryJul 31, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2019 in FDI 27. On (b)(6)2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50102688 ↗InjuryJul 29, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2020 in FDI 26. On (B)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072673 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K033922. One submission often covers many models, so check the product and lot details in each record.
- Z-1351-2012 · Mar 12, 2012 · TerminatedStraumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for surgical placement in maxillary and/or mandibular arches to p
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.